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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: FIFRA Guidelines Subdivision F-81-6 TSCA Guidelines 40 CFR 798.4100
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA method was not available yet by the time the study was conducted.

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
413-890-4
EC Name:
-
Cas Number:
82469-79-2
Molecular formula:
C28H50O8
IUPAC Name:
1,2,3-trihexyl 2-(butanoyloxy)propane-1,2,3-tricarboxylate

In vivo test system

Test animals

Species:
other: Guinea Pig/Hartley

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Neat, 50%, 25% of the agent in the range-finding study.
Neat material in the sensitization test.

b) The vehicle was 90% ethanol + 5% isopropyl alcohol used
neat or at 25% and 50% in the range-finding study or neat in
the sensitization test.

Concentration of test material and vehicle used for each challenge:
a) Test material used neat (undiluted).

b) Vehicle used neat (undiluted).
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Neat, 50%, 25% of the agent in the range-finding study.
Neat material in the sensitization test.

b) The vehicle was 90% ethanol + 5% isopropyl alcohol used
neat or at 25% and 50% in the range-finding study or neat in
the sensitization test.

Concentration of test material and vehicle used for each challenge:
a) Test material used neat (undiluted).

b) Vehicle used neat (undiluted).
No. of animals per dose:
Number of animals in test group: 24
Number of animals in negative control group: 10

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 24.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
24
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 24.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 100 %

Signs of irritation during induction:
No erythema seen in first and second inductions.  Two
animals had very slight erythema; usually non-confluent,
during the third induction while the remaining animals in
the treated group showed no erythema.

Evidence of sensitisation of each challenge concentration:
None

Other observations:
None

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Conclusions:
Citroflex B-6 is not a dermal sensitizer.